Chromatography SME

Posted 17 May 2022

Madison, Wisconsin - United States

Req Id 248445

Details

 

A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.    


Your Role at MilliporeSigma:

The Scientist, Quality – Chromatography SME position is responsible for data integrity compliance and technological advancements in the Quality Control division of MilliporeSigma. The position may also perform data review on all/some of the following: routine final product analysis, in-process tests, equipment verifications, and raw material analysis or other data generated to support quality control activities at the Madison and Verona sites. Review of data includes techniques specific to but not limited to HPLC, GC, KF, DSC, TGA, IR, NMR and XRPD among other tests and instruments. This position may be responsible for data review/approval of protocols and standard operating procedures as well as technical reports.  Other responsibilities include technical writer or review of deviations/OOS/OOT’s, change controls, and CAPA’s.  This position will be the primary trainer for HPLC/UPLC instrumentation and usage of the chromatography data software.  Additionally, participation in process improvement initiatives, working in a team environment, maintaining a clean and safe work area, and supporting the department in maintaining the laboratory in an audit ready state are other duties. The Scientist, Quality position, like all positions at SAFC, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties. 

 

ESSENTIAL JOB FUNCTIONS

  • Author and execute user requirement specifications for software and equipment within the quality control group.

  • Author Assessment Reports for software/systems for data integrity and 21CFR11 compliance in the quality control group.

  • Train new hires on HPLC/UPLC equipment including use of chromatography data system software

  • Assist other analysts/data reviewers within the quality control group with chromatography software as  software Subject Matter Expert.

  • Perform analytical data review of cGMP data in support of the quality control group to ensure accuracy and quality of data.

  • Work on complex problems in which analysis of data requires an in-depth evaluation of various factors.  

  • Exercise judgment within broadly defined procedures and practices to select technique, methods, and evaluation criteria for obtaining results.

  • Able to solve problems and make decisions with minimal assistance.

  • Able to interpret analytical data (including FT-IR, 1H NMR, MS).

  • Review of OOS and OOT investigations, deviations, change controls and CAPAs.

  • Apply problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor.

  • Meet with internal project groups to keep projects on track.

  • Maintain projects and timelines with minimal oversight.

  • Write and revise SOPs as needed.

  • Work cooperatively within the QC department and with other departments to achieve project goals.  Communicate with project management and provide technical updates

  • Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable

  • Work in a safe manner and maintain the cleanliness of the work environment.

  • Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.

 

ADDITIONAL LOCAL NEEDS

Environmental conditions:  Frequently required to wear appropriate protective gear (lab coats, safety glasses/goggles, gloves) and other personal protective equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles. 

Physical requirements:  Specific vision requirements include close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus.  Regularly use phones, computers, computer monitors, and all office/laboratory equipment.  Required to type at a computer keyboard and have the ability to read CRTs/computer monitors.

 

Who you are:

Minimum Qualifications:

  • B.S. in Chemistry, Biology, BioChemistry, or other Life Science discipline

  • 4+ years in a GLP or cGMP analytical laboratory environment 

 

Preferred Qualifications:

  • Written and verbal communication skills, as well as excellent documentation practices and attention to detail 

  • Ability to work in analytical testing lab with hazardous and toxic chemicals.

  • Knowledge and understanding of organic analytical chemistry. 

  • Technical writing skills to generate project reports. 

RSRMS

 


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.

We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.

We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.

Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture.  You can also apply and find more information at https://jobs.vibrantm.com

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 

If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

 

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

 

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

 

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